The Amsterdam 510k Workshop begins at 9am, and registration begins at 8am. A networking lunch is included in the City Cafe. Attendees receive a physical copy of the presentation slide deck, a hardcopy of the book “How to Prepare Your 510k in 100 Days,” and a flash drive with a complete set of 510k document templates. More important than what you receive, is what you will learn.
Oosterdoksstraat 4, Amsterdam, 1011 DK, Netherlands
Call for Directions & Reservations: +31-20-5300800
Click on the picture to the right in order to get reduced hotel rates when you register – Starting at 224€
- Medical Device Academy, Inc.
Medical Device Academy is a consulting firm that helps medical device companies with regulatory submissions, establishing new quality systems, internal/supplier auditing and training.
FDA eCopy is a service provided to device manufacturers and other regulatory consultants to help prepare, review, edit, print and ship FDA eCopy submisisons. We routinely prepare, review, edit, print and ship 510(k) submissions and pre-subs to the FDA with overnight FedEx shipping.
Factory-CRO is a global clinical research organization (CRO) that specializes in medical device and IVD clinical studies. The company manages clinical studies in Europe for CE marking and in the USA for FDA submissions. For more information, please download the company information sheet.
What you will learn in the Amsterdam 510k workshop
Rather than spend a little time on every aspect of a 510k submission, instead I will be focusing on the most important parts of a 510k submission with stories, examples and exercises. Our speakers will cover:
- How to select a predicate device
- How to write the indications for use (Section 4)
- How to create a testing plan
- How to manage your 510k project
- Biocompatibility (Section 15)
- Software Validation (Section 16)
- Electrical Safety & EMC Testing (Section 17) – presented by Leo Eisner
- Human Factors Testing (Sections 13 & 18) – presented by Adam Shames
- Clinical Study Testing (Section 20) – presented by Niels van Tienen
Niels will be teaching a free webinar on the topic of clinical studies on Wednesday, August 9th @ 10:00am EDT.
We will be collecting specific questions from registrants in advance to ensure that we include the areas that are most important to you. We have content from 24 webinars, covering each section of a 510k submission, and templates for each document. Therefore, we can review any section of a 510k in detail.
Register for Amsterdam 510k Workshop on October 11-12, 2017
We can also invoice you if you prefer. Just send an email to: email@example.com.
510(k) Workshop Amsterdam 2017 – Wednesday, October 11 and Thursday, October 12 – Pricing Increase $200 on August 11
- $1,195 Until August 10
- August 11 – September 10 Pricing = $1,395
- September 11 – October 10 Pricing = $1,595
Click on the button to download an information brochure
You can ONLY get the 510(k) book by attending one of Medical Device Academy’s live 510(k) workshops or by purchasing the on-line 510k course.
About Your Host
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.